udi

UDI is an acronym used for multiple concepts. The most prominent usage is Unique Device Identification, a system for identifying medical devices throughout their life cycle to improve safety and traceability.

Unique Device Identification (UDI) details:

In the United States, the UDI system is established and overseen by the Food and Drug Administration. Medical devices must carry a UDI on their label and packaging, and device data are submitted to the Global Unique Device Identification Database (GUDID), which provides public access to device information. A UDI consists of two parts: the device identifier (DI), which identifies the device model, and the production identifier (PI), which includes production-related details such as lot or batch, serial number, manufacturing date, and expiration date.

In the European Union, UDI requirements are implemented under the Medical Devices Regulation (MDR) and are associated with the EUDAMED database, intended to enable similar traceability across the EU. The UDI framework is designed to support post-market surveillance, recalls, adverse event tracking, and supply chain management. Manufacturers must assign and submit UDIs once the systems are in force; timelines have varied by device class and region.

Beyond medicine, UDI can stand for other organizations or programs in different countries or industries; the exact meaning depends on context.